The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published the first version of the Union list of critical medicines.
Including over 200 active substances of medicines for human use, the list has been created to help avoid potential shortages of medicine in the EU.
Shortages of medicine can cause significant harm to patients and could pose serious challenges to health systems.
Medicines are considered critical if they are used for serious diseases that cannot be replaced by other medicines, including a wide range of therapeutic areas, vaccines and medicines for rare diseases.
Carried out with all EU member states, the Union list of critical medicines considers medicine that is critical for human use across healthcare systems within the EU/EEA to ensure supply security and prevent shortages of critical medicines.
The new list reflects the outcome of the review of 600 active stakeholders from six national lists of critical medicines and was assigned in alignment with the agreed methodology developed in consultation with key stakeholder groups, including patients, healthcare professionals, organisations and industries.
As well as not impacting already-existing or to-be-established national lists of critical medicines, the Union list will support the network’s efforts in drawing up national lists where they currently do not exist.
Furthermore, it will also support and expedite the EC’s analysis of the supply chain of critical medicines to distinguish possible vulnerabilities.
The union list will be expanded in 2024 and updated annually.
The new version follows the EMA’s announcement in October of two new documents: a solidarity mechanism and a toolkit to address the critical medicine shortages within the EU.
Developed by the EMA Medicines Shortages Steering Group, the published documents enabled member states facing critical shortages to aid each other in obtaining medicine stock.
In the autumn and winter seasons of 2022 to 2023, a monitoring and supply approach was used to combat the widespread critical shortages of antibiotics in the EU.
The critical shortage was a catalyst for coordinated action involving a revision of pharmaceutical laws and the establishment of new measures to address challenges in the EU’s medicine supply.